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Post by agedhippie on Jun 1, 2023 17:36:59 GMT -5
...What I don't know is how many GLP1 users the India trial has. ... Per protocol; none as it's an exclusion criteria ("Use of glucagon-like peptide 1 receptor agonists, thiazolidinediones, or weight loss drugs in the past 3 months.") CIPLA is not trying to prove superiority. They are there to get sign-off and be able to sell Afrezza as that's all they need.
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Post by agedhippie on Jun 1, 2023 7:47:33 GMT -5
Aged- I think from the Phase 1 trial we know more than a single dose will not kill a healthy person - "The primary objective of the trial was to evaluate the tolerability of ascending doses of the investigational product as determined by the incidence and severity of reported adverse events. Secondary endpoints included pharmacokinetic parameters of plasma GLP-1 and pharmacodynamic parameters of plasma insulin and glucose" We also know that they did not get the typical vomiting - "GLP-1 plasma concentrations peaked very quickly, with a max occurring less than 3 minutes after inhalation. Even in subjects that achieved plasma GLP-1 concentrations in excess of 100 pmol/L, the nausea and vomiting characteristically associated with such levels was not observed." ... www.diabetesincontrol.com/positive-results-for-inhaled-glp-1-cpd/The nausea result is interesting but would need to be repeated on Type 2 diabetics who were not fasting over a period of time. The theory goes that the nausea and vomiting is caused by the slowing of the digestive process (you see the same effect with Symlin, and gastroparesis). The advice to avoid nausea is eat small meals, fasting fits that guide The trial found that the GLP-1 cleared in about 20 minutes so the question would be if that is long enough to have a material effect on glucose levels which given the mechanisms GLP-1 uses may be difficult. The drug would need to be modified to avoid fast clearance which could take time, but once that is done it would definitely be worth a small study at least. A daily, or longer, dosing interval combined with no nausea would be huge (although I am skeptical about the lack of nausea in normal diet)
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Post by agedhippie on May 31, 2023 18:37:58 GMT -5
Check the investor conference. I think he said more. It was the RBC conference around the 21:00 minute mark - paraphrasing slightly, "1.5 to 2.0 % mark which places it at the same point as GLP-1".
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Post by agedhippie on May 30, 2023 22:58:31 GMT -5
What is it about mnkd that does not get fair value while lqda seems to be over valued? This injustice has been going on for over a decade. Is our management team so bad since Al passed that wall street fails to analyze the potential value? Management team is always something that Wall Street takes into account. ...Plus LQDA only has 64.5M shares outstanding whereas MNKD has 264M shares outstanding. Share count matters because the profits are spread thinner - it's why share buybacks are popular with investors.
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Post by agedhippie on May 30, 2023 17:01:40 GMT -5
Traders are trying their best to keep us humble while we await the next quarterly. Many of us would rather not hear good news about MNKD, because it so dependably predicts a share price decline. Meanwhile, inexplicably, LQDA rises, with a SP 20% higher than MNKD. Wall street: You have to love it. It is so quintessentially tilted in favor of game playing. There was news that LQDA has secured financing based on equity, winning litigation on patents, and royalties of sales. Plus they have misleading statements about dosing capabilities with their inhaler. I am curious what misleading statements they are putting out about their inhaler. (LQDA dropped twice as much as MNKD today )
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Post by agedhippie on May 30, 2023 17:00:47 GMT -5
I thought what Stevil said was I was exaggerating things and his patients really did not see these symptoms. Maybe I don't remember correctly. Aged - how should I take your comment as a good thing or bad - the symptoms usually subside after the first month". My god, who wants to be that sick for a month especially if Peter Richardson was correct and TS GLP1 solves that issue. It would also be interesting to see if with TS if they can better control the dosage so the weight loss is not as severe so they lose less muscle mass. Richardson had no focus on weight loss when they ran the phase 1. What Stevil actually said - Mostly, if you start at the correct dose and titrate slowly, most patients tolerate it without much issue. Maybe the first day they’ll be uncomfortable, but not really enough of a reason to stop treatment. Notice the word "mostly"? His other point - if it was that ghastly why is it easily in the top 10 drugs every week? The short answer is because for most people it's not a problem. The problem with inhaled GLP-1 is that nobody know how it will behave beyond that a single dose will not kill a healthy person. It's several years out even assuming it works and they can solve the delayed action which, I suspect, is why there hasn't been much done on it. The muscle loss would be the same since that's down to the inherent calorie restriction.
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Post by agedhippie on May 30, 2023 9:22:28 GMT -5
Had a conversation over dinner over the weekend where GLP1 (Ozempic) came up. The horror stories sounded crazy. I assumed they must be fabrications because they sounded so outlandish. The shots, nausea, but worst of all (I thought) was the weight loss was concentrated in muscle mass, not fat cells with the result being that a larger percentage of body mass is fat then before taking the drug. No idea if that's true, but if so, that ought to be very concerning. Sports will correct me if I am wrong here because I may well be as I am not sure where I got this idea from... If you try and lose weight by diet alone (which Ozempic effectively is) your body will destroy the material that takes the least energy to replace which is muscle. You need to exercise as well in which case your body sees you are using the muscle and instead breaks down fat since muscle would need to be immediately replaced wasting energy. With Ozempic you will lose fat, but you are also going to lose muscle unless you exercise - effectively "skinny fat". The symptoms usually subside after the first month. Stevil talked about this in an earlier post about what he sees in his patients.
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Post by agedhippie on May 26, 2023 12:42:31 GMT -5
It's noticed from this morning's report that V-Go scripts seem to be climbing nicely. Hopefully, Afrezza's will soon. If you look at the long term chart you can see that the trend is downwards. This product peaked back in late 2019/early 2020 and has more or less halved since then. Since MNKD bought V-Go in May 2022 the monthly TRx has dropped 17% (5.37k to 4.46k). That said, legacy products can be very profitable even as they decline as Computer Associates proved if manufacturing costs are managed.
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Post by agedhippie on May 26, 2023 10:48:52 GMT -5
The earnings call is where you announce breaking news because the analysts are there. The AGM is about conducting company business so they are low profile affairs for the most part. I thought the AGM was more of a social event where there are drinks the night before the meeting and then some informal discussions with management and other shareholders after the 10 minute "formal" non-event. I think Mike got the message and it will be back in Danbury next year. Ah, that's the associated patting and burping of shareholders.
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Post by agedhippie on May 25, 2023 15:38:15 GMT -5
No breaking news announced in asm. Here comes the beat down on sp. The earnings call is where you announce breaking news because the analysts are there. The AGM is about conducting company business so they are low profile affairs for the most part.
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Post by agedhippie on May 25, 2023 15:35:18 GMT -5
EOFlow is an insulin patch company. Does it compete with V-Go? It sounds to me like it does the same thing but EOFlow might be smarter. It competes with the VGO in the same way that a Ferrari competes with a bicycle. The EOPatch pump is controlled from you smart phone and supports multiple basal profiles, the V-Go is driven by a spring and the profile is fixed by the spring strength. The EOPatch is more of a competitor for the Omnipod Dash. The point of the EOFlow purchase for Medtronics is that it is a potential closed loop system (EOPancreas) and has FDA breakthrough device designation in that class. More importantly; I suspect that Medtronics wants a patch pump to compete with Omnipod. The Tandem and Medtronics pumps have a large upfront cost, and the Omnipod doesn't. Over the life of the device the costs are pretty much a wash, but Medtronics wants a product to compete in Omnipod's disposable pump market.
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Post by agedhippie on May 24, 2023 17:54:48 GMT -5
... As far as schools, how do they handle shots and pumps today? I would think taking a puff of afrezza would be easier. What do they do today when a kid is playing basketball and their pump gets screwed up. Afrezza sound easier to me for the school nurse. With afrezza Mom doesn't need to worry about the night time lows. You are right AID as long as it doesn't break is the way to go during the night for best control but the kids don't want them and now don't need them. BTW- did I mention my cousin died when his pump went crazy when he was sleeping. I am not a big pump fan. Schools are used to handling pumps and injections, they are required to be by the ADA (Americans with Disabilities Act) and have been doing it for years. As for a pump get screwed up when a kid is playing basketball - thousands of kids use pumps and play sports today and they seem to survive. Anyway since this is a concern here is a site listing basketball players with Type 1 - www.chrisdudley.org/news/professionalbasketballplayerswitht1dMoms will worry about night time lows (and highs btw.) regardless of how their kid is treated. The kid is still using insulin (Afrezza and basal), still liable to get lows occasionally as your body does things regardless of insulin or carbs. For teens drink can be a real problem as it drops your glucose output and your basal insulin takes you low, ditto exercise. You have never mentioned your cousin. That's sad, but these days your CGM should catch that before things get that out of control (CGM alarms are not quiet, and the high risk alerts cannot be simply silenced).
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Post by agedhippie on May 24, 2023 17:40:10 GMT -5
Some moms wield swords and become downright militant when looking out for their kids. I expect endos to continue to work for money and will try to steer patients toward the easiest path (for the endo) as long as the easy path is not too dangerous. IF a mom finds out about Afrezza for her kid and becomes militant for it, she will affect an endo's opinion of what is easy. The way this will play is that the mom will come in having read an article on Afrezza, the endo will say that it's only part of the picture and the new pumps continually monitor and adjust giving better overall control, and Afrezza is probably not covered by your insurance. The mom will now waiver, is she choosing a bad option for her kid, after all the endo is the expert? And in the kid ends up on a pump. The plus side is that if the mom sticks to her guns and insurance isn't a problem then the kid probably gets Afrezza since ultimately the endo is not going to the wall over this. For kids who are not capable of managing their own insulin 24x7 then an AID pump (Omnipod 5, Tandem Control-IQ, or god help us a Medtronics 780G) will be more or less the automatic choice.
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Post by agedhippie on May 24, 2023 17:27:49 GMT -5
... The CGM and a weekly basal is not very interesting and provides limited value. Except to the CGM manufacturers. There is a reason Dexcom and Abbott did the work to get that use case approved.
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Post by agedhippie on May 23, 2023 22:11:42 GMT -5
Lets see - how is "afrezza + basal" MDI? I thought the M was for multiple? If icodec is as good as Mike is saying then it would be SWI (single weekly)and afrezza. These guys have to sell pumps in the future. Whats their pitch? Wear this thing but don't slide into second base with it on and maybe you can have almost as good control as you would with afrezza when you are eating? BTW - you will have better control when you are sleeping, maybe? I don't think the kid is buy it. Now do you see the future problem the pump reps are up against? The kids are not going to want them. The orders will dry up regardless of the endos pushing them. Do you see the future? In the world of the kids, afrezza is not competing with AID pumps. The kids don't won't them and they could care less about a little better control when they are sleeping. If mom doesn't need to worry about a severe low in the middle of the night, everyone is happy. The pump will be competing to get that portion of the market where afrezza is not a good fit. The issue with the Affinity trials was dosing. It said right in the protocol they could do follow-up dosing but they did not do it and the current label is bad. It makes it seem like a 4u is like 4u of subq. It is what it is. It took Mike years to figure this out while all he needed to do was read Proboards years ago. The good news is now he has and it seems like they got the word to the India Trial based on Mike's comment. If they did and they really are getting 1.5-2% A1c reduction that is a Big F'ing Deal. If Mike kept his eye on the 2024 Medicare package and afrezza will no longer need pre auths in 2024 afrezza in the T2 market is off to the races. I am sure our CGM friends will be more than happy to now with a 2% A1c reduction promote afrezza use so they can sell a CGM in the Medicare market. MDI is where you manually take meal time insulin and a daily basal. If you talk to an endo that's what they understand by that. Pump sales are doing just fine, but hey, we can watch and see if pump sales go off a cliff to be replaced by Afrezza. Care to predict a timeline for that? If mom is worried about a low in the night then an AID pump is definitely the way to since it will adjust. To be fair pumps have had basal profiles that change your basal since they started, the difference with the AID pumps are that they can respond dynamically. Does it matter? Yes, because your basal glucose output varies throughout the night peaking just before dawn hence basal profiles which Iodec obviously cannot do. Personally I think pediatrics could double Afrezza sales but I don't think it does more than that. It's going to have less impact in the earlier age groups because you can't trust a young kid to manage their insulin so they will stay on pumps. Then there is the problem with school and how school nurses are going to be with Afrezza. Pumps will just be easier and so endos will push them. If you read the CTRI trial entry the protocol and dosing are literally identical to the 175 trial with the exception that they dropped several of the secondary outcomes. Nobody is going to care though because if you are evaluating oral meds only vs. oral + insulin the latter always wins and would even if you were using the old animal insulins - that's not a surprise. I await the news that Afrezza will no longer require prior authorization with interest. when should we hear that?
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